Study title:
A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC)
EU record number:
B/BE/11/BVW1
EudraCT number:
2011-001468-23
Pharmaceutical study code:
TG4010.14
Company / Sponsor:
Transgene
Phase:
IIb/III
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Non-Small Cell Lung cancer
Therapeutic approach:
Immunotherapy
Genetic modification:
sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
Method of transfer of nucleic acid of interest:
Attenuated Vaccinia Virus (Ankara Strain)
Administered biological material:
Recombinant Attenuated Vaccinia Virus
Route of administration:
subcutaneous
Locations in Belgium:
Antwerpen, Libramont, Liège, Gosselies;
CU: ZNA Middelheim;
Centre hospitalier de l'Ardenne;
CHU Liège;
Clinique ND de Grâce, Gosselies;
Ziekenhuis Oost-Limburg;
Centre Hospitalier de l'Ardenne
Nr of subjects:
1018 worlwide - 30 patients foreseen in Belgium
Foreseen duration:
4 years
Type of procedure:
Contained use and Deliberate release
Current status:
Authorized
Information for the public
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Public information presented according to the provisions of Directive 2001/18/EC
Information related to the decision procedure
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30 September 2011 : The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
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21/11/2011: The Federal Minister gives a final decision (positive) for this trial.